WASHINGTON — With a few weeks left in his tenure as commissioner of the Food and Drug Administration, Dr. Scott Gottlieb on Wednesday moved to restrict sales of flavored e-cigarettes to try to reduce the soaring rate of teenage vaping.
The agency issued a proposal requiring that stores sequester flavored e-cigarettes to areas off limits to anyone under age 18. Retailers, including convenience stores and gas stations, will be expected to verify the age of their customers.
“Evidence shows that youth are especially attracted to flavored e-cigarette products,” Dr. Gottlieb said in a statement, “and that minors are able to access these products from both brick-and-mortar retailers as well as online, despite federal restrictions on sales to anyone under 18.”
The rate of teenage vaping has risen sharply in the last few years, with 3.6 million middle and high school students reporting that they vaped last year, according to a study by the Centers for Disease Control and Prevention. But teenage smoking continues to be at record lows, alongside the general decline in smoking rates, a pattern that public health experts warn could be reversed if nicotine addiction spurred by vaping leads young people to traditional tobacco products.
Last fall, the F.D.A. began a crackdown on teenage vaping, threatening to ban most flavored e-cigarettes and warning retailers to stop selling the products to minors. It stopped short of prohibiting the flavors.
But the proposal issued on Wednesday outlines details for how retailers must wall off the areas where the products can be sold. For stores that are open to consumers of all ages, the guidelines call for a physically separated room, a spokesman said, adding that stores cannot simply hang a curtain to create a space where flavored e-cigarettes could be sold.
Retailers, including convenience store and gas station owners, are on Capitol Hill this week, lobbying against the F.D.A.’s proposals. Some have threatened to fight the restrictions in court.
Lyle Beckwith, a senior vice president for the National Association of Convenience Stores representing thousands of retailers, said the group did not believe the F.D.A. had the authority to impose the new requirements. “The Tobacco Control Act clearly indicates they cannot discriminate against a specific channel of distribution, which is exactly what they are doing.”
Conservative groups and vaping trade associations also have come out in opposition, saying that the agency’s efforts to regulate the e-cigarette industry amount to government overreach.
The new restrictions do not apply to menthol, mint or tobacco flavors, which the F.D.A. wants to keep available for adults who are using e-cigarettes to quit smoking combustible cigarettes.
The F.D.A. will also track youth use of menthol and mint e-cigarettes, Dr. Gottlieb said. If they become too popular, he added, the F.D.A. will reconsider the exemption. Such a move would be especially harmful to Juul Labs. The vaping giant, under F.D.A. pressure, has already moved sales of its flavored e-cigarettes online, except for menthol, mint and tobacco, which it sells in stores.
But some public health advocates say the moves are too late.
“While this announcement sounds big and bold, it isn’t really,” said Micah Berman, an associate professor at The Ohio State University College of Public Health and Moritz College of Law. “The F.D.A.’s announcement exempts mint/menthol, which is the most popular flavor with kids and one that makes it easier to initiate use. And in any event, most kids are getting these products online or through older friends, not buying them in convenience stores.”
The proposal also calls for banning the sale of many flavored cigars.
“The data also indicate that eliminating flavors from cigars would likely help prevent cigar initiation by young people,” Dr. Gottlieb said. Under the new plan, cigar companies would have 30 days to remove the products from the market, and would have to apply for F.D.A. approval to go back on the shelves.
In addition, all e-cigarettes, cigars and related products not on the market by Feb. 15, 2007, must seek F.D.A. approval to sell them by August 2021. As part of their application, manufacturers must prove that their products are beneficial to public health. The agency’s original deadline for these products to comply with new, tougher regulations was extended by Dr. Gottlieb from August 2018 to 2022. Wednesday’s action chops one year off that extension.
The plan issued on Wednesday is still a draft, and must undergo a 30-day comment period before it can be finalized. It’s an unusual regulatory approach, neither a new rule, nor a voluntary guideline. Instead, the F.D.A. is telling e-cigarette makers that if their products are sold in violation of this request, they can be taken off the market, and forced to apply for agency approval. The F.D.A. can do this under its discretionary enforcement authority.
Dr. Gottlieb is scheduled to have stepped down by that time, and Dr. Norman E. (Ned) Sharpless, director of the National Cancer Institute, was named this week to replace him as acting commissioner.
Dr. Sharpless has expressed support for the e-cigarette crackdown to reduce teenage use. In his comments, Dr. Gottlieb stressed that the Trump administration has backed the plan.
Also drawing opposition is the agency’s request in the president’s budget released on Monday to collect an estimated $100 million in user fees from e-cigarette makers, similar to the fees imposed on tobacco companies and other manufacturers, to help enforce regulations aimed at teenage vaping.
Liz Mair, a Republican political consultant who founded Vapers United, a group that supports tools to stop smoking, said the user fee was equivalent to a tax on the industry and would raise prices on alternatives to traditional smoking.
“If your concern is improving public health, either as a matter of altruism and ethics or pure concern for taxpayers’ pocketbooks,” she said, “your policy should generally be to keep vapor taxes lower than cigarette taxes to incentivize people to try to quit smoking using them.”
